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In 1990, Congress enacted the Sanitary Food Transportation Act that directed the Department of Transportation to promulgate regulations for the transportation of food to ensure its safety. DOT issued a proposed rule in 1993, but later determined that it lacked the expertise to implement the law. Congress amended the law in 2005 giving FDA the authority to implement it, but with no deadline for rule making. Section 111 of the Food Safety Modernization Act directed FDA to promulgate final regulations no later than 18 months after enactment of the act. FDA published a proposed rule on February 5, 2014.

In response to requests from stakeholders, FDA extended the May 31, 2014 comment deadline on its proposal to establish sanitary transportation requirements for vehicles and transportation equipment. The new deadline for public comment is July 30, 2014. In a May 8 letter, 22 industry groups sought a 90-day extension and said they needed more time to consider several sections of the proposed rule that could have “unintended consequences.” FDA granted a 60-day extension. The agency has a court-ordered deadline of March 31, 2016 for issuing the final rule.

The proposed rule on sanitary transportation of human and animal foods is one of seven regulations mandated by the Food Safety Modernization Act.

As I mentioned in the February issue, this rule is a key component of the implementation of FSMA’s provisions. The sanitary transportation rule deals with requirements for refrigeration of food, cleaning of vehicles between shipments, and protection of food during transportation. The proposed rule would establish requirements for vehicles and transportation equipment and operations, as well as for training, records and procedures for waivers.

With some exceptions, the rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food enters interstate commerce. It would also apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container if it will be consumed or distributed in the United States.

Among the exemptions are the transportation of raw agricultural commodities performed by farms. Also exempt are shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. Food that is transshipped and not meant for consumption in the U.S. is also exempt, as well as shelf-stable foods, compressed food gases and live food animals.

According to FDA’s estimates the proposed sanitary transportation rule will impact 83,609 businesses and the average cost is estimated at $1,784 per business in the first year, for a total of $149.1 million. The ongoing annual cost to the regulated companies is estimated at over $30 million.

As you will see elsewhere in this issue, I will be participating in a FSMA panel with CFSAN Director Michael Landa and former CFSAN Director Robert Brackett at the IFT annual meeting in New Orleans in a June 23 1:30 p.m. session. And it’s a safe bet that this proposed transportation rule will feature there among other hot topics.

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